You are required to write a consent letter for your NCU IRB application if all of the following are true:
You will write a consent letter so that potential participants have all the information about your study in one place and can make an informed decision as to whether they want to participate in your study. A consent letter is just one part of the informed consent process. Informed consent is an ongoing process that begins during recruitment and continues throughout the study.
If you are engaging with participants in real-time (interviews, focus groups, observations, etc.), you may send potential participants a copy of the consent letter before you meet with them. You then must do the following:
If you are distributing an Online Survey or Questionnaire, you will do the following:
After you have received IRB approval. You should not consent participants or collect data until you have IRB approval.
You are required to use the NCU IRB consent letter template below, unless you are working with an IRB/ HRPP that is requiring you to use their template.
You will also be required to provide a Readability Report for your consent letter.
No! Using a required template is not plagiarism. The consent letter template has language that is required by federal regulations. You should not change or revise any of the template language.
If you have multiple participant groups who are all doing the same activities and answering questions about the same topics, you will use 1 consent letter for all groups. You should add subheadings to the eligibility section to clearly label each group and list the criteria separately for each group. Review the Consent Letter Examples for assistance.
If any of your participant groups are doing different activities or answering questions about different topics, you will use a separate consent letter for each group.
The NCU IRB recommends that you receive feedback on your consent letter before you submit your IRB application:
You will upload your consent letter in the "Consent Procedure & Materials" section of your IRB application.
The documents you upload to your IRB application should be ready to send to the participants. Double-check the following: